As a result of this mix-up, patients may unintentionally take Hydrocodone and acetaminophen tablets, instead of the intended dose of Phenobarbital. Unintentional administration of Hydrocodone can lead to serious adverse events including respiratory depression, CNS depression, coma and death, especially in opioid naïve patients and patients on other CNS depressants. Unintentional administration of acetaminophen may result in liver toxicity in patients on other acetaminophen containing medications, patients with liver dysfunction, or people who consume more than 3 alcoholic beverages a day. Additionally, missing doses of Phenobarbital could result in loss of seizure control.

RECOMMENDATION: Consumers who have affected product should stop using the product and contact Qualitest at 1-800-444-4011 for reimbursement. Lot numbers can be found on the side of the bottle.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program: